Micro-invasive device

ABSTRACT

An apparatus for removing tissue and/or other material from a patient, particularly a breast of a patient, is provided. The apparatus generally includes a handpiece and a tissue removal mechanism connected thereto. The tissue removal mechanism includes a cannula having an open distal tip and an outer diameter of less than about 5 mm, or less than about 2 mm. The mechanism further includes a rotatable element having a distal portion with helical threading. The distal portion of the rotatable element extends beyond the open distal tip of the cannula in order to allow tissue to prolapse between turns of the helical threading. The apparatus is designed to draw soft tissue into the cannula upon rotation of the rotatable element and without the need for supplemental sources of aspiration.

RELATED APPLICATION

This application is a continuation of application Ser. No. 11/888,321,filed Jul. 30, 2007, which is a continuation of application Ser. No.10/667,768, filed Sep. 22, 2003, which application is a continuation ofSer. No. 10/093,765, filed Mar. 8, 2002, which claims the benefit ofU.S. provisional application Ser. No. 60/278,128, filed Mar. 23, 2001and Ser. No. 60/281,848, filed Apr. 5, 2001 and Ser. No. 60/305,178filed Jul. 13, 2001 and Ser. No. 60/322,909, filed Sep. 17, 2001 andSer. No. 60/342,436, filed Dec. 21, 2001, the disclosure of each ofwhich is incorporated in its entirety herein by reference.

FIELD OF THE INVENTION

The present invention relates generally to medical devices, and, moreparticularly, to micro-invasive devices and methods for removing breasttissue for biopsy and treatment.

BACKGROUND OF THE INVENTION

The medical industry is constantly evolving through the adaptation ofimproved pharmaceutical, biotechnology, and medical device products andprocedures. Techniques and technologies are being developed to treatinternal areas of the body through less invasive means.

It is often desirable and frequently necessary to remove a portion oftissue from humans and other animals, particularly in the diagnosis andtreatment of patients with cancerous tumors, pre-malignant conditionsand other diseases or disorders. Typically, in the case of cancer, whenthe physician establishes by means of procedures such as palpation,x-ray or ultrasound imaging that suspicious circumstances exist, abiopsy is performed to determine whether the cells are cancerous. Biopsymay be done by an open or percutaneous technique. Open biopsy removesthe entire mass (excisional biopsy) or a part of the mass (incisionalbiopsy). Percutaneous biopsy, on the other hand, is usually done with aneedle-like instrument and may be either a fine needle aspiration (FNA)or a core biopsy. In FNA biopsy, individual cells or clusters of cellsare obtained for cytologic examination and may be prepared such as in aPapanicolaou smear. In core biopsy, as the term suggests, a core orfragment of tissue is obtained for histologic examination which may bedone via a frozen section or paraffin section. The type of biopsyutilized depends in large part on circumstances present with respect tothe patient and no single procedure is ideal for all cases. However,core biopsy is extremely useful in a number of conditions and continuesto be used frequently by the medical profession.

To arrive at a definitive tissue diagnosis, intact tissue is needed froman organ or lesion within the body. In most instances, only part of theorgan or lesion need be sampled. However, the portions of tissueobtained must be representative of the organ or lesion as a whole. Inthe past, to obtain tissue from organs or lesions within the body,surgery had to be performed to locate, identify and remove the tissue.With the advent of medical imaging equipment (x-rays and fluoroscopy,computed tomography, ultrasound, nuclear medicine, and magneticresonance imaging) it has become possible to identify smallabnormalities even deep within the body. However, definitive tissuecharacterization still requires obtaining adequate tissue samples tocharacterize the histology of the organ or lesion. For example,mammography can identify non-palpable (not perceptible by touch) breastabnormalities earlier than they can be diagnosed by physicalexamination. Most non-palpable breast abnormalities are benign; some ofthem are malignant. When breast cancer is diagnosed before it becomespalpable, breast cancer mortality can be reduced. However, it is oftendifficult to determine if pre-palpable breast abnormalities aremalignant, as some benign lesions have mammographic features which mimicmalignant lesions and some malignant lesions have mammographic featureswhich mimic benign lesions. Thus, mammography has its limitations. Toreach a definitive diagnosis, tissue from within the breast must beremoved and examined under a microscope. Early biopsy techniques forreaching a definitive tissue diagnosis for non-palpable breast diseaserequired a mammographically guided localization, either with a wiredevice, visible dye, or carbon particles, followed by an open, surgicalbiopsy utilizing one of these guidance methods to lead the surgeon tothe non-palpable lesion within the breast.

Open surgical breast biopsies have many drawbacks. They can bedisfiguring, expensive and are imperfect open surgical biopsies alsocarry a small mortality risk (due to the risks of anesthesia) and amoderate morbidity rate (including bleeding, infection, and fracture ormigration of the localizing wire). In cases where multiple lesions arepresent in the breast, a surgeon is reluctant to biopsy each lesion dueto the large tissue mass that must be extracted with each lesion. Themost convenient lesion may be taken which most often results in anincomplete diagnosis.

Percutaneous breast biopsy techniques are more desirable in manyinstances, particularly in light of modern imaging techniques which areable to pinpoint nonpalpable tissue masses in the breast andconsequently, the increased frequency of biopsies that are necessary fordiagnosis of these tissue masses. A well known instrument used quiteextensively for core biopsies in the past is manufactured by TravenolLaboratories of Deerfield, Ill., and is sold under the mark “TRU-CUT.”This manual biopsy instrument at one time enjoyed as much as 98% of themarket for such devices. As disclosed in U.S. Pat. No. 3,477,423, theinstrument comprises a two-piece assembly: an outer cutting cannulamounted to one hub member and an inner stylet with a sampling notchground into it mounted to a second hub, with the hubs being slidablyinterlocked. The instrument is assembled and placed into the body withthe outer cutting cannula just to the rear of a lancet point or beveleddistal end of the stylet. Upon inserting the device up to or in front ofthe area to be biopsied, advancement of the assembly is halted. Thestylet is manually advanced distally of the cannula with the cannulaheld stationery. Upon advancement of the stylet, the specimen notch isexposed. Tissue surrounding the stylet prolapses into the specimen notchand the cutting cannula is then manually advanced distally over thestylet, slowly shearing off the tissue entrapped in the stylet'sspecimen notch. The instrument is then either (a) withdrawn and thestylet advanced distally to expose the tissue for preparation for studyor (b) left in place and only the stylet is proximally removed fromwithin the cannula so a determination of successful sampling may bemade. If the sampling was not successful, the stylet may be reinsertedinto the cannula, which remains positioned within the patient, and anattempt to reposition the assembly of stylet and cannula and repeatsampling can be made.

Such a technique using this basic design of a biopsy instrument isreferred to as a manual technique. One drawback to the manual techniqueis that it requires a great deal of manual dexterity and motorcoordination, along with the use of both hands, to advance the styletwhile maintaining the position of the cannula and then to maintain theposition of the stylet while advancing the cannula. Another drawback isthat the cannula is advanced relatively slowly, resulting in anextremely poor cutting action and allowing the surrounding tissue anopportunity to collapse, thus making no use of the stored kinetic energyin the material being severed. Further disadvantages are encounteredwhen the tissue volume to be sampled contains areas of higher densitythan that of surrounding tissue, such as areas of calcification commonlyassociated with certain types of cancerous growths. A manually insertedsampling device is often incapable of penetrating the denser area oftissue which merely deflects the course of the cannula/stylet structurearound the dense area and into the more compliant surrounding tissue. Inthe late 1980's, two different stereotactic guidance systems weremodified to allow the guiding portion of each system to accommodatespring powered devices such as the Biopty® (Bard Radiology) gun. As usedherein, the term “gun” is used to refer to a tissue sampling devicedesigned for “one-handed” operation. A feature common to many of thesedevices is the shape of the device being adapted to fit the hand of amedical practitioner with a pistol-like grip, complete with a triggeringmechanism. Free-hand ultrasound guidance techniques were also developedto guide the Biopty® gun to breast lesions detected by ultrasound.

With image-guided percutaneous core breast biopsy, it should be possibleto greatly reduce the number of open, surgical breast biopsiesperformed. However, there are limiting factors with image-guided breastbiopsies. Conventional, manually operated two-step devices are awkwardto manipulate, and the tissue samples obtained thereby are oftenunsatisfactory.

A variety of automatic and semiautomatic biopsy instruments have beendeveloped which are spring loaded gun-type devices. A biopsy guncurrently used is described in U.S. Pat. No. Re. 34,056, entitled“TISSUE SAMPLING DEVICE,” issued to Lindgren et al. Additional examplesof biopsy gun devices are disclosed in U.S. Pat. Nos. 4,600,014 and4,958,625.

Such devices use a design comprising a handle held in a physician'spalm, and a guide tube extending forwardly of the handle. A cannula isslidably disposed within the guide tube and is movable from within theguide tube forwardly out of the distal end of the guide tube. A samplingstylet is telescopically disposed within the cannula and projects fromthe rear of the handle. In an automatic mode of operation, the cannula,when in the retracted position, is spring loaded by means of acompressed spring. A release lever, which works against the compressedspring, is activated to release compression of the spring which thenexpands and pushes the cannula outwardly over the stylet. Thisinstrument, as stated, requires two handed operation. Also, since thestylet is not removable proximally from within the handle, the entireinstrument must be withdrawn to obtain access to the sample.

A fully automatic instrument manufactured by Radiplast, Inc. of Swedenis described in U.S. Pat. No. 4,699,154. This instrument comprises areusable, spring-loaded box-shaped housing or handpiece, which activatesa disposable cannula and stylet set. Both the stylet and cannula areactivated in rapid succession. The instrument has the advantage ofreducing the dexterity and motor coordination necessary in the use ofmanual devices and also eliminates the slow cutting action of themanually advanced cannula, replacing it with a very quick, clean cut.This instrument, however, also has its drawbacks. First, the reusablehandpiece is very large, heavy, cumbersome, and expensive. They are alsotypically spring-powered devices and must be manually cocked with somesort of plunger bar. Such “cocking” of the gun requires considerableforce and the gun must be cocked for each biopsy cut. When actuated, thesprings provided in the gun accelerate the needles until a mechanicalstop position is reached which can create a loud snapping noise andjerking motion which is a problem both to the physician and the patient.A further drawback is encountered in automatically activating both thestylet and the cannula, as opposed to activating the stylet manually, inthat the rapid speed at which the cannula follows the stylet into thetissue does not allow much tissue to collapse into the specimen notch,limiting the size of the sample.

U.S. Pat. No. 5,183,054, entitled “ACTUATED BIOPSY CUTTING NEEDLE WITHREMOVABLE STYLET,” issued to Burkholder et al., discloses a biopsydevice having a tubular cannula through which a stylet, having a styletcavity near the distal end, is placed. The stylet is removable from thecannula and removed from the biopsy device through the housing so thatthe tissue sample obtained by the biopsy device may be manuallyretrieved while the cannula remains in place within the patient, nearthe area being sampled. Thereafter, the stylet may be reinserted throughthe housing and cannula into the patient's tissue where additionaltissue samples may be obtained. In this way, trauma to the tissue thatordinarily occurs upon reinsertion of the cannula and stylet isminimized.

U.S. Pat. No. 5,234,000, entitled “AUTOMATIC BIOPSY DEVICE HOUSING APLURALITY OF STYLETS,” issued to Hakky et al. describes a biopsy devicefor taking a plurality of samples of tissue from a living being. Thedevice comprises a housing having a portion arranged to be held by aperson using the device, a cannula having a proximal portion and adistal portion and being coupled to the housing. A plurality of styletsare located in the housing, with each of the stylets having a proximalend, a distal end, and a tissue receiving notch located adjacent thedistal end. Each stylet is individually propelled through the cannulainto the body so that a portion of the tissue prolapses into the notch.

There currently exists a need for a more effective microsurgical devicefor obtaining a sample of breast tissue from a patient.

SUMMARY OF THE INVENTION

New apparatus and methods for removing breast tissue and/or othermaterial from a human breast have been discovered. The present inventionprovides apparatus, for example, micro-invasive apparatus, to removetissue or other material from a target area of a breast to provide oneor more benefits, such as diagnostic benefits, therapeutic benefits andthe like.

The apparatus of the invention are useful for removing unwanted,diseased, or even healthy bodily materials, for example, tissues, formedical treatment and/or therapeutic purposes. Advantageously, thepresent invention is suitable for use in many surgical settings and issuitable for performing various material removal procedures usingmethodologies, for example, in terms of methods of introducing theapparatus into the body and removing the apparatus from the body, whichare substantially analogous to conventional surgical techniques.Necessary or desirable adaptations of the apparatus of the presentinvention for specific medical treatment, e.g., diagnostic, andtherapeutic purposes will be readily appreciated by those of skill inthe art.

Accordingly, apparatus for removing tissue from a target area of abreast are provided. In one broad aspect, the apparatus comprise ahandpiece and a tissue removal element connected or coupled thereto. Thetissue removal element includes a cannula, for example, a substantiallyrigid or flexible cannula, and a rotational element disposed in thecannula. The rotational element is connected to a source of rotationalenergy, for example, a motor. The rotational element is disposed atleast partially in the cannula. The cannula includes an open distal tipstructured to be placed in a breast, and preferably a proximal endconnected, for example, removably connected, to the handpiece. Thetissue removal element is structured and effective to draw breast tissueor other material from the target area or site, for example, into theopen distal tip, in response to, for example, as a result of, rotationof the rotational element relative to the cannula.

In one embodiment, the rotational element is structured to at leastassist in drawing material from a breast into the cannula. For example,the rotational element and the cannula cooperatively engage to form orcreate a source of suction sufficient to draw the tissue or othermaterial into the cannula in response to rotation of the rotationalelement relative to the cannula. Advantageously, the cannula, inparticular the interior hollow space formed or defined by the cannula,and the rotational element are sized and positioned, relative to eachother, to create a source of suction or pumping action in response tothe rotational element rotating relative to the cannula. Without wishingto limit the invention to any particular theory of operation, it isbelieved that this functioning of the cannula/rotational elementcombination is at least somewhat analogous to the functioning of a pump,for example, a pump based on the principles of the “Archimedes' screw”,causing the material to be drawn or pulled or pumped into the opendistal tip of the cannula and through the cannula in being removed fromthe target area of the human/animal body.

Preferably, the suction/pumping action created or formed by thecannula/rotational element combination is itself sufficient andeffective so that no other, for example, no additional or supplemental,source of suction or pumping action is employed, needed or required toeffectively remove material from the target area in accordance with thepresent invention.

In one embodiment of the invention, the rotational element includes ashaft and one or more outwardly extending projections, for examplethreads, preferably having a substantially helical configuration.Advantageously, the rotational element includes a distal portion withsuch projections or threads. The proximal portion of the rotationalelement may or may not include such projections or threads. In a veryuseful embodiment, the proximal portion is substantially free of suchprojections or threads.

The distal portion of the rotational element, in a useful embodiment,extends beyond the open distal tip or inlet of the cannula, for example,by a distance in a range of about 0.02 inches to about 1 inch beyond theopen distal tip of the cannula. For example, the distal portion mayextend a distance equal to at least about one-half of the spacingbetween adjacent projections or threads. The rotational element distalportion may extend a distance equal to more than about one spacing, forexample, about two spacings or more between adjacent projections orthreads beyond the open distal tip of the cannula. More specifically,the rotational element advantageously further includes an elongatedshaft having a proximal portion which is substantially smooth to allowsufficient annular space between the shaft and cannula for removal ofmaterial.

The cannula may be of any suitable size. However, in order to obtain thereduced invasiveness benefits of the present invention, it is preferredthat the cannula size have an outer diameter of no greater than about 5mm and more preferably about 2.0 mm or smaller.

It has unexpectedly been found that the present apparatus including suchsmall size cannulas not only provide for reduced, or even micro,invasive procedures (which reduce surgical trauma and promote healing)but also are effective in removing materials from a body to achievetherapeutic benefits, for example, therapeutic removal of healthy ordiseased breast tissue, fluidic cystic materials, soft tissue tumors,and the like.

In one embodiment of the invention, the open distal tip of the cannulais angled or is beveled with respect to a longitudinal axis of thecannula. Alternatively, the open distal tip is substantiallyperpendicular with respect to the longitudinal axis of the cannula.

The present apparatus advantageously includes a tissue collectionchamber in communication, for example, fluid communication, with thecannula and structured to collect and contain material, for examplebreast tissue, that is passed through the cannula. The collectionchamber preferably is structured to facilitate quantification and/orother analysis of the removed material. In one particularly usefulembodiment, the collection chamber comprises a substantially transparentconical section removably engaged to a housing of the handpiece andpreferably circumscribing a portion, for example, the proximal portionof the shaft of the rotational element.

The cannula and/or the rotation element, preferably both, advantageouslyare structured to be manually deformable, for example, to enable thephysician to alter the normal configuration, for example, the normalsubstantially straight configuration, thereof to create a curvedconfiguration if desired, for example, to deal with the material removalapplication at hand.

In another broad aspect of the present invention, methods of removingmaterial from a breast of a human or an animal are provided. Suchmethods comprise placing into a breast of a human or an animal a cannulahaving an open distal tip and a rotational element disposed at leastpartially in the cannula and rotating the rotational element relative tothe cannula, thereby at least assisting in drawing a material from thebreast into the open distal tip of the cannula. The method preferablyfurther comprises passing the material from the breast through thecannula. Apparatus in accordance with the present invention describedherein, can be advantageously employed in accordance with the presentmethods.

The cannula used in accordance with the present methods preferably haveouter diameters of about 5 mm or less, or about 2.0 mm or less.

The placing step of the present methods preferably includespercutaneously introducing the cannula into the human or animal breast,and positioning the open distal tip of the cannula in close proximity tothe material to be removed. The cannula and rotational elementpreferably are sized and positioned relative to each other so that therotating step is effective in drawing the material from the breast of ahuman or an animal into the open distal tip of the cannula. Preferably,the material from the breast is removed without applying additionalsuction or aspiration to the open distal tip of the cannula.

In one very useful embodiment, the rotating of the rotational elementrelative to the cannula is effective to draw the material into thecannula as a substantially single, continuous often times substantiallycohesive piece. Thus, although some shearing and/or cutting of thematerial to be removed may occur in accordance with the presentinvention, for example, so that the removed material is compatible withthe space within the cannula through which the material is to be movedproximally, the present apparatus and methods preferably are not basedon cutting or chopping the material to be removed into small discretesegments.

The present methods preferably further comprise collecting the materialremoved and/or observing and/or otherwise testing the material removed.

Any suitable material can be removed from the body of a human or ananimal using the present apparatus and/or methods. Preferably, suchmaterial to be removed can be effectively removed using the presentapparatus and/or methods without employing or requiring additionalsuction or aspiration, beyond that formed or created by the rotation ofthe rotational element relative to the cannula.

Advantageously, the material to be removed is soft and/or semi-solidand/or a viscous flowable material and/or a material which is at leastsomewhat free to move toward a source of lower pressure or suction.

Incorporated herein by this specific reference are U.S. Patentapplication for Micro-invasive Tissue Removal Device, having Serial No.(attorney docket no. D-3034), filed on even date herewith, and commonlyassigned herewith, and U.S. Patent application for Micro-invasiveNucleotomy Device and Method, having Serial No. (attorney docket no.D-3039) filed on even date herewith, and commonly assigned herewith.

Each and every feature described herein, and each and every combinationof two or more of such features, is included within the scope of thepresent invention provided that the features included in such acombination are not mutually inconsistent.

The present invention and the objects and advantages thereof will bemore clearly understood and appreciated with respect to the followingDetailed Description, when considered in conjunction with theaccompanying Drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a side view of a micro-invasive breast tissue removalapparatus in accordance with the present invention including a handpieceand a tissue removal element connected thereto.

FIG. 2 is a partial cross-sectional view of the apparatus taken alongline 2-2 of FIG. 1.

FIG. 3 is a partial cross sectional view of a preferred distal tip ofthe tissue removal element of the apparatus in accordance with thepresent invention; and

FIG. 4 is side view of the apparatus shown in FIG. 1, with the tissueremoval element having a curve for facilitating access to breast tissue.

FIGS. 5 and 6 each show a partial cross sectional view of an alternativedistal tip of the tissue removal apparatus of the present invention.

DETAILED DESCRIPTION

Turning now to FIGS. 1 and 2, a micro-invasive tissue removal apparatusfor removing tissue or other material from a breast, in accordance withthe present invention is shown generally at 10. The apparatus 10generally comprises a handpiece 14 and a tissue removal mechanism 16 tobe described in detail hereinafter.

The handpiece 14 is preferably sized and contoured to fit comfortablywithin a palm of a surgeon, and includes for example a molded plastichousing 22. As shown in FIG. 2, the housing 22 of the handpiece 14encloses a small motor 24 and a power supply, for example a 9 voltbattery 26 for driving the tissue removal mechanism 16. Suitableelectrical connectors 27 are provided. For convenient, one handedoperation, an ON/OFF switch 28 is preferably provided on a recessed,lateral portion 29 of the housing 22.

Turning now as well to FIG. 3, the tissue removal mechanism 16 generallyincludes a cannula 30 and a rotatable element 34 disposed therein. Asshown most clearly in FIG. 3, the cannula 30 includes a distal portion40 defining an inlet 42 for receiving tissue drawn from a target areawithin a patient. The inlet 42 is defined, for example, by flat, distaledge 44 of the cannula 30. The distal edge 44, in the embodiment shownin FIG. 3, lies along a plane that is substantially perpendicular withrespect to the longitudinal axis of the cannula 30. During operation ofthe apparatus 10, as will be described in greater detail hereinafter,breast tissue and/or other material is drawn, suctioned or pumped,through the inlet 42 and into a cylindrical bore 46 defined between thecannula 30 and a shaft 50 of the rotatable element 34.

In a preferred embodiment of the invention, such as shown in FIGS. 1-3,the tissue removal mechanism 16 is structured to draw breast tissue orother material into the cannula 30 by a pumping action produced byrotation of the rotatable element 34, preferably without the use ofsupplemental aspiration or other means for drawing tissue into thethreaded distal portion 52 or cannula 30. In other words, the rotationalelement 34 and the cannula 30 are designed to cooperatively engage toform a source of suction that is, in itself, sufficient to draw thematerial into the cannula 30. Advantageously, the present invention 10has been found to be safe and highly effective for removing soft tissuesfrom a breast of a patient, for example, less invasively, without beingconnected to external sources of aspiration or other external machinesand devices. In the preferred embodiment of the invention, therotational element 34 includes a distal portion 52 which extends beyondthe open distal tip (defined by edge 44) of the cannula 30. Morepreferably, the distal portion 52 extends a length of about 0.066 inchesbeyond the cannula distal edge 44. A blunt, rounded tip 53 of therotational element 34 is preferably provided.

As shown, the rotational element 34 includes one or more outwardlyextending projections, for example threads such as helical threading 56shown, disposed about at least a portion of the shaft 50, for urgingtissue into the bore 46. Preferably, outer radial edge 58 of thethreading 56, or other projection, is disposed closely proximate aninner wall 62 of the cannula. As shown, the distal end 52 of therotational element 34 extends at least one-half thread turn beyond thecannula inlet 42. This structure allows breast tissue or other materialwithin the breast to prolapse between the outer, distal-most threadingturns, and be pulled into the inlet without necessarily being discretelycut or severed by the threading 56. The present invention is designedsuch that upon insertion of the open distal tip of the cannula 30 intothe target region of the breast of a body, tissue or other material willprolapse into and at least partially fill the open spaces between theprojections or threading 56. Rotation of the rotational element 34, forexample at about 12,000 RPM, causes the material to be pulled in aproximal direction proximally into the bore 46, for example, as acontinuous piece or strand of material.

Although the threading 56 is only shown as a single thread located onthe distal portion 52 of the rotational element 34, it is to beappreciated that in some embodiments of the invention, the threading 56may involve multiple threads, and/or may be disposed on more proximallylocated portions of the rotatable element shaft 50. Furthermore,although only about 4.5 turns of threading 56 are shown, it is to beappreciated that in some embodiments of the present invention, fewer ormore than 4.5 turns of threading 56 may be provided. It is alsocontemplated by the present invention that rather than continuousthreading 56, the shaft 50 may be provided with discontinuous threading.It is contemplated that with appropriate modifications and the like,these and other structures may be provided which would operate in amanner similar to the pumping action provided by the structure shown.

Preferably, the cannula 30 has an outer diameter of less than about 5mm, for example, an outer diameter of about 2.0 mm or less. The cannula30 is made of any suitable, medical grade material or materials, but ispreferably somewhat rigid but bendable.

Advantageously, as will be appreciated by those of skill in the art, theapparatus 10 of the present invention is minimally invasive to thepatient. For example, the cannula 30 can be introduced into the targetarea of the breast of the patient by means of a conventional, rigidstylet (not shown) disposed through the cannula 30 (detached from thehandpiece 14). The cannula/stylet are introduced percutaneously throughthe skin, underlying muscle/fatty tissue and into the target area withinor adjacent a breast such that the inlet 42 is positioned within orclosely adjacent the target tissue or other material. The stylet is thenremoved and the cannula 30 is left in place. The rotational element 34,attached to the handpiece 14, is then introduced into the cannula 30.This procedure may be facilitated through the use of fluoroscopy orx-ray imaging techniques as known in the art, which do not requiredirect endoscopic or direct viewing of the target tissue.

Advantageously, unlike prior art surgical breast tissue removal devices,the action of the tissue removal mechanism 16 urges tissue into thecannula 30 in many instances a substantially continuous segment ratherthan in relatively smaller, distinct portions of the tissue. Generally,the cannula 30 and rotational element 34 are structured to cooperativelyfunction in a manner that will form a source of suction within thecannula 30 when the rotational element 34 is rotated while the cannulainlet 42 is disposed within the target tissue. It has been found thatthe level of suction so created is sufficient to gently and effectivelydraw soft tissue, for example gelatinous, viscous, or any suitabletissue that can be drawn by the action of the present invention into thecannula without need for any other, for example, supplemental, source ofsuction applied to the inlet 42. For example, the suction formed orcreated is sufficient to pull or soft tissues into the open tip withoutcausing damage to other structures.

The tissue removal mechanism 16 can be left to remain in substantiallythe same position within the target area of the breast during the tissueremoval procedure, or alternatively may be advanced, or withdrawn duringthe procedure, for example in a direction along the longitudinal axis ofthe cannula in order to facilitate tissue removal.

FIG. 4 shows another advantageous feature of the present invention. Thetissue removal mechanism 16 may be structured to be deformed, forexample, manually deformed, into a curve shape such as shown. Theflexibility and deformability of the tissue removal mechanism 16 allowscustom shaping or curving of the apparatus 10 for further facilitatingaccess to tissue.

Unlike prior art devices designed to remove substantially liquidsubstances, the present invention can be used to remove highly viscoussubstances.

FIG. 5 shows an alternative cannula distal portion 40 a, which isbeveled, includes sharp distal tip 80, and a relatively wider inlet 42 athan inlet 42. Also shown is a narrower threading 56 a (relative tothreading 56 of FIG. 3) on rotational element 34 a. It is contemplatedthat in some embodiments of the present invention, a beveled cannula maybe provided (such as in FIG. 5) and the rotational element may besomewhat recessed within the cannula, in that it does not extend furtherthan a distal-most tip 80 thereof. Thus, it is contemplated that as longas at least a portion of threading is exposed to tissue through theangled inlet, the tissue will be drawn into the inlet 42 a andeffectively removed upon rotation of the rotatable element.

FIG. 6 shows a cannula distal portion 40 similar to that shown in FIG.3. However the rotational element 34 a is similar to that shown in FIG.5, having narrow helical threading 56 a, and a flat tip 53 a rather thanthe rounded tip 53 shown in FIG. 3.

As shown in FIGS. 1, 2 and 4, the apparatus 10 may further comprise acollection chamber 70, for example, defined by a subhousing 72 removablyengaged to the housing 22. More specifically, the collection chamber 72is in fluid communication with a proximal portion 76 of the cannula 30.For example, the collection chamber 70 is adapted to collect,temporarily contain, and allow analysis of breast tissue or othermaterial, for example during and/or after the tissue removal procedure.

Generally, the collection chamber 70 is structured to contain materialthat is drawn from the surgical site. The removed material enters thecollection chamber 70 as shown by arrows 74 in FIG. 2. The collectionchamber 70 is preferably adapted to allow observation of the tissuematerial during the procedure. For example, the subhousing 72 may betransparent. In addition, the collection chamber 70 is preferablystructured to allow quantification or measurement of the tissue, forexample, the subhousing 72 may be provided with suitable indices (notshown) showing milliliters (ml) of material collected therein. After thetissue removal procedure, the breast tissue may be biopsied usingconventional means. As shown, a proximal portion 78 of the rotatableelement 34 is circumscribed by the collection chamber 70.

It is further contemplated that in many applications of the presentinvention, the cannula 30 may alternatively or additionally be used as apassageway for introducing medication and other agents into the targetregion of the breast before or after the tissue removal, if desirable.

It can be appreciated that the present apparatus is less invasive andmore passive in comparison to other percutaneous breast tissue removaldevices in the art. Despite its simplicity and passivity, the presentdevice is designed to be highly effective in removing soft tissue, forexample, cystic materials, fatty tissue, and muscle tissue or othermaterials that may be found in the breast. Because there is no externalsuction source or supplemental aspiration required to pull material intothe cannula, it can further be appreciated that the apparatus issmaller, safer and requires less monitoring than devices that include aseparate or external source of suction or additional idler shafts forremoving material.

It is also to be appreciated that the apparatus of the present inventionmay be modified to include a connector for enabling the handpiece to beconnected to an external aspiration source. In this case, means formonitoring the vacuum level in the cannula is preferably provided inorder to indicate and prevent buildup of excess vacuum in the event thecannula becomes clogged for example.

While this invention has been described with respect to various specificexamples and embodiments, it is to be understood that the invention isnot limited thereto and that it can be variously practiced within thescope of the following claims.

1. An apparatus for removing a gelatinous substance from a target areaof a human body, the apparatus comprising: a handpiece; a cannulaincluding a proximal end portion structured to be coupled to thehandpiece and an open distal tip adapted to be placed in the target areaof the human body prior to the proximal end portion being coupled to thehandpiece; a rotational element disposed at least partially in thecannula, wherein the apparatus is structured so that the rotationalelement and the cannula cooperatively engage to form a source of suctioneffective in drawing a gelatinous substance from the target area of thehuman body into the cannula in response to rotation of the rotationalelement; and the apparatus including no external source of suction. 2.The apparatus of claim 1, wherein the handpiece is sized and contouredto fit comfortably within a palm of a surgeon.
 3. The apparatus of claim1, wherein the cannula is sized and structured to be rigid and manuallydeformable.
 4. The apparatus of claim 3, wherein the cannula and therotational element are manually deformable into a desired curved shape.5. The apparatus of claim 1 which further comprises a motor.
 6. Theapparatus of claim 1, wherein the cannula has an outer diameter nogreater than about 5 mm.
 7. The apparatus of claim 1, wherein therotational element is structured to rotate at a sufficiently high speedto cause the gelatinous substance from the target area of the human bodyto be pulled proximally into the cannula.
 8. The apparatus of claim 1which further comprises a source of battery-powered rotational energy.9. The apparatus of claim 8 which further comprises a battery coupled toand effective to provide power to the source of battery-poweredrotational energy.
 10. An apparatus for removing a gelatinous substancefrom a target area of a human body, the apparatus comprising: ahandpiece; a cannula including a proximal end portion structured to becoupled to the handpiece and an open distal tip adapted to be placed inthe target area of the human body; a rotational element structured to beintroduced into the cannula and the target area of the human body afterthe open distal tip is placed in the target area of the human body,wherein the apparatus is structured so that the cannula and therotational element disposed at least partially in the cannulacooperatively engage to form a source of suction effective in drawing agelatinous substance from the target area of the human body into thecannula in response to rotation of the rotational element; and theapparatus including no external source of suction.
 11. The apparatus ofclaim 10, wherein the apparatus includes a motor.
 12. The apparatus ofclaim 10, wherein the cannula has an outer diameter no greater thanabout 5 mm.
 13. The apparatus of claim 10, wherein the rotationalelement is structured to rotate at a sufficiently high speed to causethe gelatinous substance from the target area of the human body to bepulled proximally into the cannula.
 14. The apparatus of claim 10 whichfurther comprises a source of battery-powered rotational energy.
 15. Theapparatus of claim 14 which further comprises a battery coupled to andeffective to provide power to the source of battery-powered rotationalenergy.
 16. A apparatus for removing a gelatinous substance from atarget area of a human body, the apparatus comprising: a handpiece; acannula including a proximal end portion structured to be coupled to thehandpiece and an open distal tip adapted to be placed in the target areaof the human body; a rotational element disposed at least partially inthe cannula and extending beyond the distal tip of the cannula, whereinthe apparatus is structured so that the rotational element and thecannula form a source of suction effective in drawing a gelatinoussubstance from the target area of the human body into the cannula inresponse to rotation of the rotational element; and the apparatusincluding no external source of suction.
 17. The apparatus of claim 16,wherein the rotational element is structured to rotate at a sufficientlyhigh speed to cause the gelatinous substance from the target area of thehuman body to be pulled proximally into the cannula.